ISO 13485 & EU MDR - Expert Advice Community

Becoming third-party certification body

If our company would like to become a third-party certification body, how do we go about this, where do we register and what processes need to be done. We are already writing SOP’s and QMS for device companies,  how can we get to become auditors and where do we register as such.

Risk Management

Our company has no prior risk management documents on any devices to prepare the risk management packages. I was thinking if I can help engineers by having some samples of similar devices to ours? What is your thought on it?

Regulatory Compliance QMS Program

Please provide a regulatory compliance QMS program specifics contents laid out in a document which is required for a high risk complex class III medical device PMA approval for US FDA and European countries.

Definition of a non-conformity

Looking for a clear definition of non-conformance. Specifically related to medical device. Would you be able to provide a clear definition of a Major and a MInor non-conformance? I have looked at the ISO standards, as well as the FDA 21 CFR guidance. I am not seeing a clear definition for these two terms.
Please advise

Risk/ Supplier - what happens if a supplier ceases trading.

Hi I wonder if i could have some advice. 

I am just working on updating my purchasing and supplier evaluation and risk assessments.  I am not sure what category this issue comes in, possibly both.  But the question is, if a medical device manufacturer goes bankrupt or ceases trading for whatver reason, and we hold product which we are looking to sell as a distributor, can we sell this? I am concious that there is no manufacturer support for the product if they are no longer around.   No post market surveillance would be able to be conducted.

Thanks, Chris 

Competent Authority Reporting

Hi 

I am looking over what to report to the competent authority for adverse incidents.  I am happy that with the information supplied by Advisera my quality manual covers that.  

I am curious about a situation though, we purchase a class 1 device from the manufacturer and sell it.  Our customer has purchased 10 this last year and 3 have broken.  I suspect it is their handling of the device.  They believe this should be reported to the competent authority (MHRA in our case) as a product defect.  

Does anyone have advice on this?  if it was a IIa or b I would possibly understand, but I am unsure here.  No adverse incident has occured from this, no one has been harmed.

OQC Standard as Importer

Hello again,

I'm preparing ISO 13485 QMS as Importer in Europe. Our scope of work is "Sales, Logistics and Warranty Service".

To ensure safety and quality of our product, we should conduct outcome inspection (OQC) after we repair the defective devices or reworks.

However, we do not have any inspection standard or test report forms yet. 

The question is, "Do we have to have identical inspection standard(criteria) and OQC test report as our Manufacturer?"

Any feedback would be very appreciated. 

ISO 13485 as Importer

Hello, 

I'm preparing to get ISO13485 certified as Importer. 

We are importing medical devices (class I) in Europe, implement warranty service and sell to EMEA/CIS area. 

I know it's not a requirement to get ISO13485 as Importer but we should get it by main customer's request. 

In this case, There are several questions I would like to ask. 

1. How should I set the scope of ISO 13485 certificate? Development & Manufacturing will be excluded as we only implement procurement, sales, warranty service and storage.

2. How far should I create procedures? I don't think we need to conduct all the activities what ISO13485 requires. 

3. For example to be more specific, how do we manage risk management? 

Our headquarter(Legal Manufacturer) already conduct risk management activities and have relavent risk management files.

Do we have to make risk management procedure? can we just monitor those risk management files implemented by our HQ?

or do we have to do process risk assessment? (e.g. risk assessment for each procedure) 

Your feedback would be very appreciated.

Filling documents

1. On the risk management matrix, should we include departments such as finance and administration that are not quite an essential part of the process to make and develop our product?

2. On the 9th document "Design and Developempent" there says we should include record of old versions of the designs of the product, but our question is how much records should we include? Should we include since our first design (which is from 2021) or could we just include the designs from a year ago to now? Or is there a minimum record time that must be met?

Distributor and ISO 13485

I am revising the Distributor's Agreement and wondering to what extent our quality control shall go to ensure the ISO 13485?
In other words, how much can I ask of the distributor in terms of complying with ISO 13485? 
Should the medical device distributor have ISO certification or only knowledge of it?